Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

NCT ID: NCT00551733

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2007-12-25

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving carboplatin together with paclitaxel poliglumex is more effective than giving carboplatin together with paclitaxel in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel poliglumex to see how well they work compared with carboplatin and paclitaxel in treating women with stage III, stage IV, or recurrent non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

• Compare the overall survival of patients with chemotherapy-naïve stage IIIB or IV or recurrent non-small cell lung cancer treated with paclitaxel poliglumex and carboplatin vs paclitaxel and carboplatin.

Secondary

• Compare the progression-free survival of women treated with these regimens.
• Compare the disease control in women treated with these regimens.
• Compare the clinical benefit in women treated with these regimens.
• Compare the response rate in women treated with these regimens.
• Compare the quality of life of women treated with these regimens.
• Compare the safety and tolerability in women treated with these regimens.

OUTLINE: This is a multicenter study.

Patients are stratified according to age (≥ 60 vs < 60 years old), geographical location (United States of America, Canada, or Australia vs the rest of the world), extent of disease (independent of brain metastases, i.e., brain metastases are not considered in determining extent of disease) (intrathoracic disease only vs extrathoracic disease), and ECOG performance status (0 or 1 vs 2). Patients will be randomized to 1 of 2 treatment arms.

• Arm I: Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1.
• Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the completion of study treatment by the Pain Assessment Patient Questionnaire, the Pulmonary Symptom Index, and the Functional Assessment of Cancer Therapy- Lung Cancer Subscale (FACT-LCS) (only in countries in which a validated translation is currently available).

After completion of study therapy, patients are followed at least monthly.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Given IV

paclitaxel poliglumex

Intervention Type: DRUG

Given IV

Arm II

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

carboplatin

Intervention Type: DRUG

Given IV

paclitaxel

Intervention Type: DRUG

Given IV

Interventions

carboplatin

Given IV

Intervention Type: DRUG

paclitaxel

Given IV

Intervention Type: DRUG

paclitaxel poliglumex

Given IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with known brain metastases must have received standard antitumor treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS metastases as defined by the site's institutional standards

• Neurologic function must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen
• Patients must have recovered from therapy for their brain metastases with no evidence of significant unstable neurological symptoms within the 4 weeks before study randomization
• No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology

PATIENT CHARACTERISTICS:

• Female
• ECOG performance score 0-2
• Life expectancy ≥ 12 weeks
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL (may be achieved with transfusion)
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 times ULN (CTC grade 1) (patients with Gilbert syndrome or other hereditary bilirubin defects may be included regardless of bilirubin levels)
• SGOT and SGPT ≤ 2.5 times ULN (CTC grade 0 or 1) (5 times ULN [CTC grade 0 to 2] if due to liver metastases)
• Alkaline phosphatase ≤ 2.5 times ULN except for elevated alkaline phosphatase with laboratory documentation that demonstrates bone origin
• No pregnant women or nursing mothers
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation
• No known hypersensitivity to study drugs or excipients
• Meets all of the following criteria:

• No weight loss > 10% in previous 6 months
• Lactate dehydrogenase (LDH) ≤ 600 IU/L (central laboratory) regardless of weight loss
• LDH ≤ 400 IU/L (central laboratory) and no weight loss ≥ 5% in previous 6 months
• BMI ≤ 35
• No concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer
• No neuropathy grade 2 or greater
• No clinically significant active infection for which active therapy is underway
• No unstable medical conditions including unstable angina or myocardial infarction within the past 6 months

• Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable
• No circumstance that would preclude completion of the study or the required follow-up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from major surgery
• At least 7 days since prior local palliative radiotherapy
• At least 30 days since prior radiation therapy with curative intent
• At least 4 weeks since prior investigational therapy, unless local requirements are more stringent
• No prior systemic chemotherapy for the treatment of lung cancer, including systemic radiosensitizers used to treat brain metastases or any biologic agents
• No concurrent non-protocol-specified systemic antitumor therapy
• No concurrent amifostine, investigational agents, other cytotoxic agents for this disease
• No concurrent radiotherapy (with the exception of radiotherapy for brain or bone metastases for palliative purposes or radiotherapy for a condition other than NSCLC that was ongoing at the time of randomization)

• Patients receiving palliative radiotherapy (treatment for symptomatic metastatic disease) may be treated while on study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CTI BioPharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

Fred B. Oldham, MD

Role: STUDY_CHAIR

CTI BioPharma

Locations

Scottsdale Medical Specialists

Scottsdale, Arizona, United States

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Burbank, California, United States

Southwest Cancer Care - Escondido

Escondido, California, United States

Clinical Trials and Research Associates, Incorporated

Montebello, California, United States

Stanford Cancer Center

Stanford, California, United States

Broward Oncology Associates

Fort Lauderdale, Florida, United States

Horizon Institute for Clinical Research

Hollywood, Florida, United States

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, United States

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Hematology Oncology Consultants - Naperville

Naperville, Illinois, United States

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

Olympia Fields, Illinois, United States

Cancer Center of Indiana

New Albany, Indiana, United States

Providence Medical Group

Terre Haute, Indiana, United States

Family Medicine of Vincennes Clinical Trial Center

Vincennes, Indiana, United States

West Michigan Regional Cancer and Blood Center

Free Soil, Michigan, United States

Newland Medical Associates PC - Southfield

Southfield, Michigan, United States

Hattiesburg Clinic, PA at Forrest General

Hattiesburg, Mississippi, United States

Columbia Comprehensive Cancer Care Clinic

Columbia, Missouri, United States

Kansas City Cancer Centers - South

Kansas City, Missouri, United States

Saint Louis University Cancer Center

St Louis, Missouri, United States

Las Vegas Cancer Center

Las Vegas, Nevada, United States

Veterans Affairs Medical Center - Reno

Reno, Nevada, United States

Richmond University Medical Center

Staten Island, New York, United States

Lincoln Medical and Mental Health Center

The Bronx, New York, United States

New York Medical College

Valhalla, New York, United States

Mid Dakota Clinic, PC

Bismarck, North Dakota, United States

Blood and Cancer Center, Incorporated

Canfield, Ohio, United States

Aultman Cancer Center at Aultman Hospital

Canton, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Vita Hematology Oncology at St. Luke's Hospital

Bethlehem, Pennsylvania, United States

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, United States

Family Cancer Center, PLLC - Collierville

Collierville, Tennessee, United States

Mid-South Cancer Center

Germantown, Tennessee, United States

Southwest Regional Cancer Center - Central

Austin, Texas, United States

Lone Star Oncology - Austin

Austin, Texas, United States

Mary Crowley Medical Research Center at Sammons Cancer Center

Dallas, Texas, United States

Utah Hematology Oncology, PC

Ogden, Utah, United States

Cancer Outreach Associates - Abingdon

Abingdon, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Cell Therapeutics, Incorporated

Seattle, Washington, United States

Countries

United States

References

Langer CJ, O'Byrne KJ, Socinski MA, Mikhailov SM, Lesniewski-Kmak K, Smakal M, Ciuleanu TE, Orlov SV, Dediu M, Heigener D, Eisenfeld AJ, Sandalic L, Oldham FB, Singer JW, Ross HJ. Phase III trial comparing paclitaxel poliglumex (CT-2103, PPX) in combination with carboplatin versus standard paclitaxel and carboplatin in the treatment of PS 2 patients with chemotherapy-naive advanced non-small cell lung cancer. J Thorac Oncol. 2008 Jun;3(6):623-30. doi: 10.1097/JTO.0b013e3181753b4b.

Reference Type: RESULT

PMID: 18520802 (View on PubMed)

Other Identifiers

CDR0000573340

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUDRACT-2007-004167-22

Identifier Type: -

Identifier Source: secondary_id

CTI-PGT-07-00400

Identifier Type: -

Identifier Source: org_study_id